Events

Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perform offline measurement and manipulation of CT images, diagnostic X-ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2012-RN-01103-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-10-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01103-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    1. when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately. 2. in the calcium scoring protocol, the protocol is switched to mass score but the protocol name remains agatston.3. spline measurement values do not update when adding control point (cp) and when changing the length of the line. 4. in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct cuv values. 5. loading pet images in the ct viewer (ctv) / quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.
  • 조치
    Philips is providing work around instructions for each issue and will be implementing a software update to correct the problem.

Device

Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perfor...
  • 모델명 / 제조번호(시리얼번호)
    Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perform offline measurement and manipulation of CT images, diagnostic X-ray system)ARTG Number: 119929
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA